The highlighted CTE Model Standards are covered in Unit 2 on diabetes.

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1 The highlighted CTE Model Standards are covered in Unit 2 on diabetes. A1.0 Define and assess biotechnology and recognize the diverse applications and impact on society. A1.1 Use data to explain how biotechnology fields such as pharmaceuticals, agriculture, diagnostics, industrial products, instrumentation, and research and development are impacting human life. Classroom presentations by Amgen and Medtronic Inc. demonstrated through real world examples how pharmaceuticals and industrial products and the R&D that created them impact society. A1.2 Describe the use of model organisms in biotechnology research and manufacturing. Students used E. coli bacteria to create a transgenic organism to produce human insulin A1.3 Recognize the role of innovation in creation of emerging biotechnology careers, including those in nanotechnology, biofuels, and forensics. Students learned how microsensors and microprocessors are used in the portable insulin pump created by Medtronic Inc. A1.4 Research and identify public misunderstandings related to biotechnology and discern the source of these misunderstandings. Students learned that biotechnology produces human insulin that is identical to the human insulin produced in the body, even though it was produced by a genetically modified organism GMO, the E. coli bacterium. A1.5 Evaluate the impact of biotechnological applications on both developing and industrial societies, including legal and judicial practices. A1.6 Explore and outline the various science and non-science fields and careers associated with biotechnology. A2.0 Understand the ethical, moral, legal, and cultural issues related to the use of biotechnology research and product development. A2.1 Know the relationship between morality and ethics in the development of biotechnology health care products. A2.2 Know the difference between personal, professional, and organizational ethics. A2.3 Understand the necessity for accurate documentation and record keeping. Students practiced keeping an official notebook documenting the protocols and results of their investigations; this was reinforced by the Medtronic bioengineer when he described his career in R&D. A2.4 Understand the critical need for ethical policies and procedures for institutions engaged in biotechnology research and product development. A2.5 Describe the dilemma of health care costs related to advancements in biotechnology and public access to treatments. The cost to develop, produce and run clinical tests for pharmaceuticals produced by biotechnology was discussed by the Amgen biotechnologist, siting the $95, week treatment for HepC using Giliad s new protease inhibitor regimen. A2.6 Prepare a presentation comparing the benefits and harm that can be the result of biotechnology innovations in both the research and application phases and which course of action will result in the best outcomes.

2 A3.0 Demonstrate competencies in the fundamentals of molecular cell biology, including deoxyribonucleic acid (DNA) and proteins and standard techniques for their purification and manipulation. A3.1 Define and describe the structure and function of DNA ribonucleic acid (RNA) and proteins, explain the consequences of DNA mutations on proteins. A3.2 Describe enzyme structure and function, diagram the impact of enzymes and catalysis on reaction rates, and recognize the emerging role of enzymes in replacing industrial chemicals. A3.3 Employ standard techniques of DNA extraction, purification, restriction digests, bacterial cell culture, and agarose gel electrophoresis and document and evaluate results. A3.4 Employ standard protein techniques, including antibody production, enzyme assays, spectrophotometry, gel electrophoresis, and chromatography and document and evaluate results. A3.5 Predict outcomes of DNA and protein separation protocols. All of these standards are covered in the Amgen Biotech Experience ABE in which the students clone the human insulin gene into an expression vector, use it to transform E.coli bacteria to produce the gene product, and then purify the insulin by column chromatography. The background information is covered in both the ABE and the PLTW Principles of Biomedical Science curriculum of Unit 2. A4.0 Recognize basic concepts in cell biology and become familiar with the laboratory tools used for their analysis. A4.1 List and describe the structure and function of cellular organelle. In order to understand how insulin and glucagon are synthesized and secreted by the pancreas cells, they learn about chromosomes / chromatin in the nucleus, the nucleolus as the site of ribosome formation for translation, the synthesis of the hormone in the rough endoplasmic reticulum, its migration and modification through the smooth endoplasmic reticulum, formation of transition vesicles which transport the hormone to the Golgi where it is modified, sorted and packaged into secretory vesicles, how it is transported to the plasma membrane by microtubules to be secreted under specific conditions. A4.2 Describe conditions that promote cell growth under aseptic conditions in the laboratory and workplace. Students grow transformed E. coli bacteria on LB agar plates and in liquid culture. They learn about lag phase, logarithmic growth, and stationary phase during bacterial growth. A4.3 Use various methods to monitor the growth of cell cultures. Students follow bacterial growth of cells in liquid culture by measuring turbidity, optical density, and DNA and protein levels. A4.4 Explain the basic concepts of cell growth and reproduction, DNA replication, mitosis, meiosis, and protein synthesis. Students need to know these concepts as they culture the bacteria in the ABE so they know at what point to concentrate and lyse cells in order purify the insulin produced by the bacteria. A4.5 Discuss the structure and function of the macromolecules that compose cells, including carbohydrates, lipids, DNA, RNA, and protein molecules. Students learn the structure

3 and function of these biological macromolecules as well as how to quantify them in food samples and stomach contents as part of their analysis of Anna Garcia s diet. A4.6 Distinguish between prokaryotic cells, eukaryotic cells, and viruses. A4.7 Conduct indicator tests for the common macromolecules of the cell. Students use indicator tests to detect the presence of the 4 classes of biological macromolecules in food samples and stomach contents. A5.0 Integrate computer skills into program components. A5.1 Use the Internet and World Wide Web to collect and share scientific information. A5.2 Use a variety of methods, including literature searches in libraries, computer databases, and online for gathering background information, making observations, and collecting and organizing data. A5.3 Compile labs (results, tables, graphs) in a legal scientific notebook and/or an Internet site or Web page. Students use Excel to create data tables and graph the relationships between dependent and independent variables in the investigations of Unit 2, and they keep all of their data, analyses and conclusions in a research notebook. A6.0 Implement use of the metric system, orders of magnitude, and the ph scale in preparation of reagents, analysis of data, and graphing. A6.1 Apply knowledge of symbols, algebra, and statistics to graphical data presentation. Students calculate averages of data, determine standard deviations and standard errors of the mean for statistical analysis, and graphically follow logarithmic growth of bacterial cultures. A6.2 Prepare solutions based on both percent and weight composition to demonstrate proficiency in use of mechanical and digital microbalances. Students prepare molar, mass % and volume % solutions for agarose gel electrophoresis and for biochemical determinations of cellular metabolites. A6.3 Calculate and prepare solutions of various molarity; calculate and prepare buffers of various ph; and prepare serial dilutions. As described above, students prepare various solutions, many of which need to be adjusted to specific phs, and dilutions needed to be prepared for the dialysis study of hyper- and hypo-glycemic effects on cells. A6.4 Create data tables and graphs using Excel for the purpose of collecting and analyzing data. See A5.3 above. A7.0 Understand the function of regulatory agencies for the biotechnology industry and the lasting impact of routine laboratory and communication practices on product development and manufacturing. A7.1 Identify agencies at the local, state, and federal levels. A7.2 Be aware of the role of agencies in promoting patient safety, quality control, and entrepreneurship. A7.3 Describe intellectual property. Intellectual property was discussed by both the biotechnologist from Amgen and the bioengineer from Medtronic when they descirebed the process of R&D that was used to create their products. A7.4 Understand a patent and use online resources to search a patent database.

4 A7.5 Demonstrate accurate record keeping and follow good laboratory practice (GLP) for lab notebooks. A7.6 Articulate issues of ethical concern, including plagiarism, copyrights, trademarks, and patents and use online data resources and searchable databases to investigate a copyright, trademark, or patent. A8.0 Follow sustainable and safe practices with high regard for quality control. A8.1 Follow written protocols and oral directions to perform a variety of laboratory and technical tasks. Students follow prescribed protocols and techniques in the ABE as well as the other investigations of Unit 2. A8.2 Recognize laboratory safety hazards using safe practices to avoid accidents. Imbedded in both the PLTW Principles of Biomedical Science and ABE curricula are the safety protocols that are routinely practiced in the biotechnology field. A8.3 Locate and use Material Safety Data Sheets (MSDS). All reagents that have MSD sheets have the information presented in the protocol descriptions so students are aware of the dangers of the substance and the emergency actions to take. A8.4 Outline the appropriate responses to a laboratory accident including identification of location and use of emergency equipment. Students learn the safety practices and emergency actions to take each time they have a new protocol or piece of equipment to use. A8.5 Practice laboratory and personal safety including the location and use of emergency equipment (personal protective equipment, no food or drink, no open-toe shoes). All personal and laboratory safety practices are routine practiced in the lab. Students must pass a lab safety test before they can perform any laboratory activity. A8.6 Properly and safely use and monitor a variety of scientific equipment, including ph meters, microscopes, spectrophotometers, pipets, micropipets, and balances. Students use all laboratory equipment by following all of the acceptable laboratory safety practices. A8.7 Determine which equipment is appropriate to use for a given task and the units of measurement used. By using all of the laboratory equipment required in the investigations of Unit 2, students learn which piece of equipment is used to measure which parameters. A8.8 Perform specimen collection, label samples, and prepare samples for testing. A8.9 Handle, transport, and store samples safely. A9.0 Understand that manufacturing represents inter-connectedness between science and production. A9.1 Describe the major steps of a product s move through a company s product pipeline. The biotechnologist from Amgen described A9.2 Identify several products obtained through recombinant DNA technology. A9.3 Outline the steps in production and delivery of a product made through recombinant DNA technology. Students performed these steps as they used genetic engineering to produce insulin and purify it. A9.4 Cite examples of plant parts or extracts used as pharmaceuticals.

5 A9.5 Use the Internet to find information about traditional pharmaceuticals, herbal remedies, and recombinant pharmaceuticals. A9.6 Evaluate the impact of robotics and automation on aseptic processes. A9.7 Design a flow chart describing the steps for creating a new drug from hypothesis to distribution.